Attachment A - Draft Statement of Work (SOW) 75F40125Q00003.docx

DRAFT STATEMENT OF WORK

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

PROFESSIONAL, SCIENTIFIC, AND NON-SCIENTIFIC SUPPORT AND PANDEMIC READINESS

Table of Contents

DRAFT STATEMENT OF WORK

CENTER FOR DEVICES AND RADIOLOGICAL HEALTH (CDRH)

PROFESSIONAL, SCIENTIFIC, AND NON-SCIENTIFIC SUPPORT AND PANDEMIC READINESS

Background The Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.

The mission of the Center for Devices and Radiological Health (CDRH) is to protect and promote the public health. CDRH assure that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and safe radiation-emitting products. We provide consumers, patients, their caregivers, and providers with understandable and accessible science-based information about the products we oversee. We facilitate medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.

To assist the CDRH in fulfilling its mission, the Center requires consultants that have sufficient skilled capacity that includes general microbiology, microbiology with expertise in virology, toxicology, chemistry as it relates to material compatibility, ultraviolet sterilization, and in reprocessing of medical devices in real world settings. Additionally, the CDRH is interested in personnel with expertise in diagnostics testing, such as molecular testing, serology testing, antigen testing, infectious disease testing, clinical laboratory testing. Other specialties and studies CDRH requires includes Biology, Chemistry, Epidemiology, General Engineering, Physics, Statistics, Computer Science, Virology, Toxicology, Pulmonology, Anesthesiology, and Infectious Diseases.

During the COVID-19 State of Emergency, the CDRH acted quickly to acquire surge support to assist CDRH’s Offices with project/program management in conjunction with the CDRH’s mission. This contractor support was essential to the CDRH’s response to the COVID-19 Pandemic. In order to be prepared for a similar scenario, the CDRH requires a vendor that has an extensive database of experts that can be quickly onboarded to provide surge support during times of undue stress on the public health.

Objective The primary objective is to provide the CDRH with a vehicle to acquire the support services of advanced professional and scientific consultants to assist CDRH’s Offices with project/program and portfolio management in conjunction with CDRH’s mission.

The services provided will be critical professional and scientific expertise in support of CDRH’s mission and used for the evaluation of the continued performance, safety, and effectiveness, of vaccines, therapeutics, and diagnostics approved, cleared, licensed, or authorized for use for the treatment, prevention, or diagnosis of infectious diseases or other emerging threats; facilitation of advanced continuous manufacturing activities related to production of vaccines and related materials; facilitation and conduct of inspections related to the manufacturing of vaccines, therapeutics, and devices delayed or cancelled for reasons related to infectious diseases; review of devices authorized for use for the treatment, prevention, or diagnosis of infectious diseases; and oversight of the supply chain and mitigation of shortages of vaccines, therapeutics, and devices approved, cleared, licensed, or authorized for use for the treatment or prevention by the Food and Drug Administration.

The secondary objective is to provide the CDRH with the capability to acquire the support services of advanced professional, scientific, and non-scientific consultants to assist CDRH’s Offices during a pandemic situation that requires surge support to fulfill the CDRH’s mission during a public health emergency.

Scope The Contractor shall provide professional and scientific services to the CDRH. The consultants will foster and develop methodologies and analyses that ensure medical devices released to the market are aligned with all of the FDA and CDRH requirements and safety protocols.

Under supervision, the contractor shall provide support to managers and staff, assist with office operations, projects and special assignments. The Contractor shall coordinate logistical details associated with the departmental operations and prepares documentation for the Offices specified above. Responsibilities include providing consultation related to supporting medical device reviews; participating in meetings and teleconferences; coordinating meetings with internal and external stakeholders; correspondence; research; data analysis; writing detailed documents and reports; and other administrative office tasks related to the CDRH’s projects.

The contractor shall provide consultants / Subject Matter Experts (SMEs) across a variety of processional and scientific disciplines to assist the CDRH with the regulatory responsibilities of the CDRH. Subject matter specialties include:, but is not limited to the following:

· Anesthesiology;

· Biology;

· Biocompatibility;

· Chemistry;

· Computer Science;

· Epidemiology;

· Expertise in diagnostics testing, such as molecular testing, serology testing, antigen testing, infectious disease testing, clinical laboratory testing;

· Expertise applied to Ventilators;

· Expertise related to respirators, masks, face shields, and other forms of Personal Protection Equipment (PPE);

· General Engineering;

· General Microbiology;

· Infectious Diseases;

· Microbiology with expertise in virology, toxicology, chemistry as it relates to material compatibility, ultraviolet sterilization, and in reprocessing of medical devices in real world settings;

· Pulmonology;

· Physics;

· Scientific expertise in the regulation and approval and of medical devices;

· Statistics;

· Toxicology; and

· Virology.

Surge Support During situations that require surge support, such as public health emergencies similar to the COVID-19 Pandemic, the Contractor shall provide surge support for requirements and for additional work within the overall scope of this contract that cannot be accomplished by existing personnel.

The contractor shall constantly manage a database of expert contract support to be able to provide expert consultants across a variety of processional, scientific, and non-scientific disciplines to assist the CDRH with the regulatory responsibilities of the CDRH.

Tasks Project Management Kick-off Meeting Within 10 business days after the start of the period of performance for the Blanket Purchase Agreement (BPA), the Contractor shall participate in a Kick-Off Meeting with CDRH management and the COR.

The Contractor shall prepare summary meeting minutes, detailing the discussion held, and provide a copy of the minutes to the COR within five (5) business days after the meeting.

Weekly Report A weekly meeting (minimum 30 minutes) shall be held with the Contractor’s program manager and COR (the CO/CS will attend at his/her discretion unless directed otherwise by the COR. The Contractor shall submit a weekly meeting agenda including, but not limited to, the following items:

· Contract Administration and Funding,

· Current Contractor status, and

· Recruitment Status Risks and Issues.

Ad-Hoc Expert Consultation These Contractor shall serve as Consultants across a variety of professional and scientific disciplines to assist with the regulatory responsibilities of the CDRH. This work often involves complex, novel, controversial, and time-sensitive issues.

Contractors shall perform duties per order including but not limited to:

· Provide expert consultation to review teams in support of reviews for

· Emergency use authorizations

· 510(k), PMA and De Novo marketing applications

· Presubmission;

· Participate in on-site and remote meetings to discuss these device submissions with both internal and with external sponsors;

· Develop written reviews and other documents as needed;

· Assist CDRH Staff as needed with projects including but not limited to:

· Performing research,

· Conducting interviews,

· Attending, leading, or otherwise participating in meetings,

· Data Analysis,

· Communication with internal and external stakeholders; and

· Writing drafts of internal and external communication.

Areas of Expertise In alignment with the responsibilities of each of CDRH’s Offices, the contractor personnel shall have professional, scientific, and non-scientific expertise in appropriate fields to assist CDRH staff. Specific requirements will be addressed in each call order. Potential disciplines of expertise are related to the medical devices regulated by each Office. This includes but is not limited to:

· ophthalmic, anesthesia, respiratory, ear, nose and throat (ENT) and dental medical devices;

· cardiovascular devices;

· reproductive, gastro-renal, urological and general hospital devices;

· surgical and infection control medical devices;

· neurological and physical medicine devices;

· orthopedic devices; and,

· in vitro diagnostic, radiological health, and mammography quality standards programs.

Position Titles, Job Categories, and Descriptions The Contractor shall conduct recruitment and retention efforts to provide the following expert consultant support satisfying the requirements of this SOW. Background checks for conflict of interests (COIs), information security, and ethics training for these positions will be essential for all persons connected with FDA to ensure that no real or perceived ethical conflicts exist. The personnel proposed shall possess the required education, experience, and ability to obtain security clearances, if applicable, to perform under this contract:

· Executive Consultant

· Senior Executive Consultant

· Principal

· Project Manager

· Program Manager

· Senior Program Consultant

· Senior Consultant

· Senior Specialist I

· Technical Consultant

· Consultant I

· Consultant II

· Consultant III

· Consultant IV

· Analyst I

· Analyst II

· Analyst III

· Analyst IV

· Analyst V

· Senior Project Analyst

· Project Analyst

· Technician

· Strategic Analyst I

· Strategic Analyst II

· Strategic Analyst III

· Strategic Analyst IV

· Subject Matter Expert I

· Subject Matter Expert II

· Subject Matter Expert III

· Subject Matter Expert IV

· Subject Matter Expert V

· Subject Matter Expert VI

· Subject Matter Expert VII

· Subject Matter Expert VIII

1.1.1 Labor Category Roles And Responsibilities

Table 1: Labor Category Roles and Responsibilities

Responsible for employee recruitment and development. Adheres to applicable security, labor, and federal contracting laws. Plans daily activities within the guidelines of company policy, job description and supervisor’s instruction in such a way as to maximize personal output.

Consultant IV Provides technical, scientific and/or functional expertise in one or more key areas. Works directly with senior client management. Provides guidance, direction, best practices knowledge for key deliverables of the project. Is capable of directing research, managing project processes, and performing relevant analysis. Oversees data collection and analysis tasks that support management decision-making. May also conduct cost benefit analyses.

Experience: Minimum BA/BS, 10 years experience

Experience: Minimum BA/BS, 8 years experience

Experience: Minimum BA/BS, 6 years experience

Experience: Minimum BA/BS, 4 years experience

Experience: Minimum BA/BS, 2 years experience

Experience: Minimum BA/BS, 3 years experience.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 6 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 8 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 10 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 12 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 14 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 16 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 18 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

consulting and support, with respect to the organizational framework of the client offices to foster program improvement and sustainment. Evaluates, designs, and implements organizational strategies to maximize the potential for meeting an organization’s vision, mission, and goals. Designs and conducts studies, analyses, research; provides expert professional and consulting services; and prepares presentations and recommendations relating to the operation, program, or organization. Prepares and delivers extensive reports, conducts high-level meetings and briefings, or other presentations as required. Conducts and prepares feasibility studies and strategies. Provides expert technical advice and assistance; performs in-depth conformance reviews, audits, and evaluations. May serve as a project or task leader on highly complex, time-sensitive, and important tasks. This position is normally used on a project task(s) in a temporary capacity.

Experience: Minimum BA/BS, 20 years experience. Specialized experience in operations or management relevant to the applicable task. Excellent communication skills (verbal and written) and a demonstrated proficiency in Microsoft Windows/Office. Familiar with a variety of the field's concepts, practices, and procedures.

Pandemic Readiness: Surge Support The Contractor shall provide surge support for unforeseen or unplanned increases in level of effort required (in circumstances such as the assignment of new tasks to one of the government offices, often as a result of national emergencies, executive orders, statutory changes, Secretary of Health and Human Services instruction, etc.). These Contractors shall serve as consultants across a variety of professional, scientific, and non-scientific disciplines to assist with the regulatory responsibilities of the CDRH. This work often involves complex, novel, controversial, and time-sensitive issues.

If the CDRH requires additional staffing, the Center will release an Order describing the need for surge support. The Contractor shall conduct ongoing recruitment and retention efforts to ensure that the vendor has an extensive database of available experts to quickly onboard in an emergency situation.

Background checks for conflict of interests (COIs), information security, and ethics training for these positions will be essential for all persons connected with FDA to ensure that no real or perceived ethical conflicts exist. The personnel proposed shall possess the required education, experience, and ability to obtain security clearances, if applicable, to perform under this contract.

The Contractor must be able to effectively provide personnel who can effectively fill all of the following staff roles:

· Executive Consultant

· Senior Executive Consultant

· Principal

· Project Manager

· Program Manager

· Senior Program Consultant

· Senior Consultant

· Senior Specialist I

· Technical Consultant

· Consultant I

· Consultant II

· Consultant III

· Consultant IV

· Analyst I

· Analyst II

· Analyst III

· Analyst IV

· Analyst V

· Senior Project Analyst

· Project Analyst

· Technician

· Strategic Analyst I

· Strategic Analyst II

· Strategic Analyst III

· Strategic Analyst IV

· Subject Matter Expert I

· Subject Matter Expert II

· Subject Matter Expert III

· Subject Matter Expert IV

· Subject Matter Expert V

· Subject Matter Expert VI

· Subject Matter Expert VII

· Subject Matter Expert VIII Deliverables Deliverables are specified in Table 1. The Contractor shall deliver all products to the FDA COR, various programmatic staff, and/or CO, where applicable.

Format of Deliverables Electronic copies must be in a format compatible with Office 365 and Adobe Acrobat (version 10 or later).

Submission and Review Procedures The Contractor shall submit all deliverables to the COR, unless otherwise stated. The COR will be responsible for the review of all draft and final deliverables to ensure accuracy, functionality, completeness, professional quality, and overall compliance with the requirements of the task. The Contractor shall ensure the accuracy and completeness of all deliverables in accordance with referenced policy, regulations, laws, and directives. Unless specified otherwise, the government shall have ten (10) working days to complete the review and approve the deliverables. If deficiencies are found or areas require modification, the Contractor shall be notified and shall have five (5) calendar days to correct the deficiencies. Upon re-submission by the Contractor, the government will reapply the same acceptance criteria. If the deliverable does not meet the acceptance criteria a second time, the government may consider the Contractor as having deficient performance with respect to the subject task.

Summary Of Deliverables This table provides a list of deliverables.

Table 1: Deliverables

Note: See Section 4.2 for additional details.

Note: See Section 4.2 for additional details.

Note: See Section 4.2 for additional details.

Note: See Section 4.2 for additional details.

Contract Type The expected vehicle is a Blanket Purchase Agreement (BPA) with specific details about each need defined in resulting orders.

Place Of Performance Services shall be provided both on and off-premises. Flexibilities will be provided, at the discretion and authorization of the COR.

The contractor shall work remotely using FDA furnished property on the FDA network.

Space will be provided at FDA's White Oak Headquarters:

White Oak Campus Building 66 10903 New Hampshire Avenue, Silver Spring, Maryland 20993.

Period Of Performance The estimated period of performance is one base period of twelve months with four additional twelve-month option periods.

Holidays and Government Closures The Contractor is not required to provide on-site services on the following days that are Federal Holidays or on any other day designated as a Federal holiday, Government closure, or shut-down for the Washington, D.C. area:

New Year's Day Martin Luther King Day President 's Day Memorial Day Juneteenth Independence Day Labor Day Columbus Day Veteran 's Day Thanksgiving Day Christmas Day Note: January 20, 2025 and January 20, 2029 will be an additional Federal Holiday for the Inauguration.

The Contractor shall not schedule training during federal holidays or Government closure. As necessary, training scheduled during unexpected Government closures may be rescheduled following coordination with the COR. The Contractor shall not bill the Government for any training that the Contractor did not perform due to any Government closures.

Travel The Government does not intend travel costs (local and non-local) to be incurred during the term of this requirement. If deemed necessary and appropriate, the Contractor shall identify and forecast travel requests per each individual order, and it must be approved in writing by the CS, CO, and COR in advance (at least 10 calendar days). The travel to be reimbursed shall be in accordance with FAR 31.205-46 Travel Costs and the Federal Travel Regulation.

Government Furnished Property And Information Government furnished property (materials, equipment, and/or information) is to be provided in conjunction with required performance under this contract as determined by mutual agreement between FDA and the Contractor. The expected GFP is a government provided laptop and PIV card to access the FDA Network.

When the Government provides equipment, then the Contractor shall maintain a detailed inventory accounting system for Government Furnished Property (GFP) following contract award. The inventory accounting system must specify, at a minimum:

The Contractor shall attach an update inventory report to each MPR unless otherwise specified by the COR. In either case, the Contractor’s inventory listing must be available for Government review within one (1) business day of COR request. The Contractor shall remain responsible and accountable for all GFP for the duration of the contract and ensure the return of the property upon completion of all work required under this contract.

CDRH Property Custodian:

Cedric Amey U.S. Food and Drug Administration White Oak Campus, Building 66 10903 New Hampshire Ave Silver Spring, MD 20993 Phone: 301-796-2306 Email: Cedric.Amey@fda.hhs.gov All property, data and information provided by the Government in the performance of this order remains the property of the Government and shall be surrendered to the Government upon completion or termination of this requirement. Likewise, all deliverables generated under this requirement remain the property of the Government.

Security Requirements The Contractor shall be responsible for determining that the individuals provided to perform under this BPA will not have an adverse effect on the efficiency, effectiveness, and integrity of the FDA, and will uphold the scope of work.

The Contractor shall be expected to have all necessary credential(s) processed prior to beginning work. All Contractor personnel must have an FDA security clearance before providing services.

All necessary administrative paperwork to hire non-FDA employees must have sufficient time to be processed in the FDA systems. The process normally takes four (4) weeks, and the Contractor shall allocate sufficient time for the new hire to be processed in the FDA system prior to the commencement of work.

The position risk level for this BPA is Public Trust Position – Tier 2 with Subject.

Furthermore, the Contractor assigned to this BPA shall provide verification of completion of all mandatory FDA trainings, including Annual Security Awareness Training, if assigned an FDA laptop that allows for FDA network access.

CDRH Security and Badging POC:

Alexander Maymir (CDRH/OC) U.S. Food and Drug Administration White Oak Campus, Building 66 10903 New Hampshire Ave Silver Spring, MD 20993 Phone: (301)796-7580 Government Contacts Contracting Officer:

Name: TBD Telephone Number:

Email Address:

Contract Specialist:

Name: TBD Telephone Number:

Email Address:

Contracting Officer’s Representative:

Name: TBD Email Address:

Telephone Number:

Section 508 Standard Requirements HHS 352.239-74 Electronic and Information Technology Accessibility (December 18, 2015)

(a) Pursuant to Section 508 of the Rehabilitation Act of 1973 (29 U.S.C. 794d), as amended by the Workforce Investment Act of 1998, all electronic and information technology (EIT) supplies and services developed, acquired, or maintained under this contract or order must comply with the “Architectural and Transportation Barriers Compliance Board Electronic and Information Technology (EIT) Accessibility Standards” set forth by the Architectural and Transportation Barriers Compliance Board (also referred to as the “Access Board”) in 36 CFR part 1194. Information about Section 508 is available at http://www.hhs.gov/web/508. The complete text of Section 508 Final Provisions can be accessed at http://www.access-board.gov/guidelines-and- standards/communications-and-it/about-the-section-508- standards.

1194.21 – Software Applications and Operating Systems

1194.22 – Web based intranet and internet information and applications 1194.24 – Video and Multimedia Products

1194.31 – Functional performance criteria

1194.41 – Information, documentation, and support